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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024254 |
Receipt No. | R000027869 |
Scientific Title | A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue. |
Date of disclosure of the study information | 2016/10/02 |
Last modified on | 2018/11/23 |
Basic information | ||
Public title | A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue. | |
Acronym | The clinical trial for investigation of anti-fatigue effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI". | |
Scientific Title | A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue. | |
Scientific Title:Acronym | The clinical trial for investigation of anti-fatigue effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI". | |
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Condition | |||
Condition | The healthy adults who routinely take exercise. | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the clinical benefits, such as anti-fatigue effect, associated with ingestion of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" for the healthy adult with routinely take exercise. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Maximum rotational speed on 10 seconds high power test by bicycle ergometer at pre- and post- exercise tolerance, four-hour rest after exercise, and the next day.
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Key secondary outcomes | 1. Fatigue related scales (VAS, modified Borg scale)
2. Fatigue related biochemical examination of blood and urine 3. Amino acid analysis 4. Adverse events. (They are assessed at pre- and post-exercise tolerance, four-hour rest after exercise, and the next day except for adverse events.) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | The subjects are instructed to take 150 ml of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" at the time of pre-exercise tolerance and three times per hour during four-hour exercise. | |
Interventions/Control_2 | The subjects are instructed to take 150 ml of "Pocari Sweat" with 28g of glucose at the time of pre-exercise tolerance and three times per hour during four-hour exercise. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who routinely take exercise (Average more than one-hour exercise per day). 3. Subjects who have no abnormality in clinical problems by screening tests. 4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study. |
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Key exclusion criteria | 1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who can't take exercise tolerance by bicycle ergometer. 3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to dairy product including milk and rice. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. Subjects who don't take dairy product and rice even if there is any reason. 8. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. Pregnant or lactating women or women expect to be pregnant during this study. 11. Subjects who have cognitive disorder or who have possibility of the disorder. 12. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 13. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators. |
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Target sample size | 16 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Miyazaki | ||||||
Division name | Clinical research support center, University of Miyazaki hospital | ||||||
Zip code | |||||||
Address | Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan | ||||||
TEL | 0985-85-9577 | ||||||
yasuji_arimura@med.miyazaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of Miyazaki | ||||||
Division name | Clinical research support center, University of Miyazaki hospital | ||||||
Zip code | |||||||
Address | Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan | ||||||
TEL | 0985-85-9577 | ||||||
Homepage URL | |||||||
yasuji_arimura@med.miyazaki-u.ac.jp |
Sponsor | |
Institute | University of Miyazaki |
Institute | |
Department |
Funding Source | |
Organization | Hakusuisha Milk Industry Co. Ltd. |
Organization | |
Division | |
Category of Funding Organization | Other |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 宮崎大学医学部附属病院(宮崎県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027869 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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